An interventional study of LifeFlow in Dehydration in Children and Dehydration, sponsored by Children's Hospital Los Angeles. Completed at 1 site in United States. Open to female participants aged 1 Month to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-08.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Health services research
This is an unblinded, randomized control study examining two fluid delivery modalities for non-critical female patients with a planned transabdominal pelvic ultrasound requiring intravenous fluid boluses.
Subjects be identified during their clinical course in the ED and will be randomized to either the LifeFlow® fluid delivery or an IV fluid bolus through the Alaris® pump (standard of care). IV fluids will be provided until the subject notes the sensation of a full bladder, at which point, the standard of care clinical practice is to perform the ultrasound. The transabdominal pelvic ultrasound requires a full bladder for optimal visualization of the ovaries, adnexa, and uterus, and is the only alternative to a transvaginal pelvic ultrasound for virginal young women. All other clinical care is per standard of care. The only research component is the randomization and data collection.
204 studies on the registry are indexed under Dehydration; 29 are open to participants now.
This study's enrollment of 30 is below the median of 43 across 147 interventional studies indexed under Dehydration.
Browse Dehydration studies →Children's Hospital Los Angeles is the lead sponsor of 150 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.
Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full.
Device: LifeFlow
The LifeFlow® is a hand-operated rapid infuser designed to administer fluids to patients by a single user, for clinical situations in which a large volume or rapid infusion of fluid or colloid is required. The device delivers fluid in 10mL increments with each complete handle compression, which refills during release, automating a push-pull mechanism. The syringe then automatically refills with handle release.
Duration- Ultrasound Ordered to Completed
The primary outcome variable is the duration (minutes) of time from when the ultrasound was ordered to the completion time of the ultrasound.
Time frame: From ED (Emergency Department) arrival to discharge/admission, less than 12 hours
Total IV Fluid (mL)
Total IV fluid administered before ultrasound
Time frame: From ED arrival to discharge/admission, less than 12 hours
Duration- Full Bladder
Fluid initiation and subjective sensation of full bladder
Time frame: From ED arrival to discharge/admission, less than 12 hours
| Milestone | Alaris Pump | LifeFlow |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
The primary outcome variable is the duration (minutes) of time from when the ultrasound was ordered to the completion time of the ultrasound.
| minutes | Alaris Pump | LifeFlow |
|---|---|---|
| Duration- Ultrasound Ordered to Completed | 154.4 ± 53.2 | 114.8 ± 31.9 |
Total IV fluid administered before ultrasound
| mL | Alaris Pump | LifeFlow |
|---|---|---|
| Total IV Fluid (mL) | 1612.9 ± 654.4 | 1482.7 ± 676.3 |
Fluid initiation and subjective sensation of full bladder
| minutes | Alaris Pump | LifeFlow |
|---|---|---|
| Duration- Full Bladder | 61.9 ± 43.6 | 26.9 ± 18.9 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alaris Pump | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| LifeFlow | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Categorical(Participants) | Alaris Pump | LifeFlow | Total |
|---|---|---|---|
| <=18 years | 15 | 15 | 30 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Alaris Pump | LifeFlow | Total |
|---|---|---|---|
| Mean | 13.6 ± 2.9 | 13.9 ± 3.5 | 13.8 ± 3.1 |
| Sex: Female, Male(Participants) | Alaris Pump | LifeFlow | Total |
|---|---|---|---|
| Female | 15 | 15 | 30 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Alaris Pump | LifeFlow | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Alaris Pump | LifeFlow | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
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Plan to share: No
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Children's Hospital Los Angeles